(This blog was originally published on Medpage Today and is presented here with permission)
Disruptive innovation is a relatively new term that refers to dynamic changes in how we live our lives. Think of your smartphone and you have a good example of disruptive technology; one that replaces old tools. Who even takes pictures with a point and shoot camera any more, or uses a map to find their way? But the rise of disruptive technologies in medicine to me raises some difficult questions.
The recent announcement by a company called Color Genomics which will provide a 19 gene assay to help women assess their risk of breast and ovarian cancer could be called a disruptive innovation. For $249, a woman can have this panel of tests done at her request so long as she has a health professional order it.
And if she doesn’t have a health professional readily available, the company will be glad to provide one.
Oh, and by the way: they don’t accept insurance. They reason: the company says the cost is so low that insurance companies shouldn’t come between women and the test. And if you want genetic counseling, they will provide that too but only after the test is done — which clearly contravenes the recommendations of a number of professional and voluntary health organizations.
Another example of disruption in the laboratory world is the anticipated onslaught of direct consumer availability of laboratory studies based on minimal amounts of blood, possibly at a pharmacy near you. It is not clear for now whether a health professional will be an intermediary, but the end goal is pretty clear that patients will have the opportunity to order their own labs when they want to get them. [more]
The DIY Patient
Not that everyone thinks that is such a bad idea. Engaged patients tend to pay more attention to their health. Getting your cholesterol checked when you want to may not be such a bad idea for those who are able to understand how this fits into the larger scheme of their personal health goals. And a recent dust-up following a suggestion by entrepreneur Mark Cuban — where he tweeted that people should have every blood test available every 3 months so they can create a history of their health status — is probably only a sample of things to come.
All of this fits right into the theme of Eric Topol’s recent book “The Patient Will See You Now” which predicts substantial changes in how patients and their doctors interact in the future. Acceding more authority to the patient and giving them more freedom to do what they think best is going to be part of the equation. It’s a trend that has been building over time, and it is in its early stages as this is written.
But there is another side to the question, one that is more problematic and one that is looming large over the regulatory landscape right now.
Hand-in-hand with increased patient access to information is an increasing expectation that something will be done to better regulate those tests that the patients may be ordering. After all, how many patients — and even how many physicians — know whether some of the newer tests that technology and research have made available really give us information that will be useful as we care for our patients.
As physicians and health professionals, we are often forced to rely on information supplied by companies, labs, and hospitals that produce these tests. When a test is developed by one company or lab but offered to other laboratories to actually do the test, the Food and Drug Administration requires review and approval to determine that the test meets expectations when performed as instructed. But laboratories and hospitals that develop their own tests and perform them only in their location do not currently require such FDA oversight. These tests are called “laboratory developed tests” or “LDT” for short. They’ve also been called “home brew” tests.
Yes, the Centers for Medicare and Medicaid Services does monitor laboratories under theClinical Laboratory Improvement Amendments (CLIA), but this is a quality program that regulates the lab, not the test it has developed. So when you see that CLIA regulations are invoked, you need to know that such a designation applies only to the quality of the lab and does not tell you whether the test in question performs as intended.
Not that there aren’t many excellent commercial and hospital-based labs that develop LDTs and provide valuable information about our patients. But there are also labs which make claims for tests that are not validated and may not meet reasonable sensitivity standards (how often they detect a specific disease, for example) or how often the findings are directly related to the disease in question or may be due to another irrelevant condition (the specificity). A test can be sensitive and pick up the disease almost 100% of the time, but if it isn’t specific to the target in question then it’s true value is limited if it is also positive in many other conditions.
Currently, the FDA is in the process of developing regulations to cover LDTs. The issue is not without controversy, however, as labs claim that they don’t need additional oversight; that CLIA is sufficient. This will take a while, given the intense interest among many constituencies in the outcome. And given that the number of potential tests that would be candidates for FDA review, you can imagine how substantial the task will be to “get it right.”
Evolving Doctor/Patient Relationships
So disruption goes on in diagnostics as it does in so many areas related to medical practice. It’s not just about who you work for as a health professional or how much you get reimbursed for what you do — or even if you get reimbursed or are paid through a global fee mechanism — or who owns the hospital. Disruption gets to the core of the longstanding type of relationship that health professionals have had with patients. What used to be inviolate, namely the doctor-patient relationship, is no longer immune to other influences. The doctor is no longer necessarily “in command” of what happens to the patients, what information the patient has at their disposal, or what course of treatment a patient may select.
Just as the democratization of information was part of the Internet revolution, so will our relationships with our patients change over time. Laboratory diagnostics are just part of the larger picture, but don’t be surprised if it becomes a much larger part. You may just find yourself trying to help a patient interpret information they obtained from a test result that you didn’t order, the patient really didn’t need, and you don’t understand. For now, unfortunately “caveat emptor” in some circumstances — both for patients and those who care for them — is advice well followed.
Who would have ever thought that medical care would turn into the great disruption frontier? Well, the answer to that question is that it is no longer “if” or “when.” It is clearly “now.”
Welcome to one of our modern medical versions of the old Wild West.